FDA-Drug2022-05-11Class II
Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Macleods Pharma Usa Inc
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Sold states
Product was distributed nationwide.
Affected count
12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets
Manufactured in
666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, NJ, United States
Products
Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0832-2022Don't want to check this manually?
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